Application 075757
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 10MG | No | No |
| 002 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 20MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075757-001 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | |
| A075757-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075757-001 | AB |
| A075757-002 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2003-01-28 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075757-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075757-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075757-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075757-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075757-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075757-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075757-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075757-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075757-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075757-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075757-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075757-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075757-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075757-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075757-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075757-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075757-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075757-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075757-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075757-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075757-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075757-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075757-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075757-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075757-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075757-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075757-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075757-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075757-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075757-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075757-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075757-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075757-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075757-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075757-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075757-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075757-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075757-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075757-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075757-002 | AB | 1 | bb7c543d1eb4… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Omeprazole | OMEPRAZOLE | St. Mary's Medical Park Pharmacy | db9f071b-85f4-061f-e053-2995a90a3ff5 | 2026-06-26 | Warnings, Adverse reactions | 075757 ANDA075757 60760-868 |
| Omeprazole | OMEPRAZOLE | QPharma Inc | f6f6ad19-ff6a-7cd3-e053-6294a90ae1bf | 2026-05-11 | Warnings, Adverse reactions | 075757 ANDA075757 |
| Omeprazole | OMEPRAZOLE | Northwind Health Company, LLC | f76c23d5-26b6-cfb2-e053-6294a90aea42 | 2026-01-01 | Warnings, Adverse reactions | 075757 ANDA075757 |
| Omeprazole | OMEPRAZOLE | Preferred Pharmaceuticals Inc. | 0fb314cb-6291-422c-98ff-24d8449992f6 | 2025-04-23 | Warnings, Adverse reactions | 075757 ANDA075757 |
| Omeprazole | OMEPRAZOLE | Chartwell RX, LLC | 4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e | 2025-02-12 | Warnings, Adverse reactions | 075757 ANDA075757 |
| Omeprazole | OMEPRAZOLE | Sandoz Inc | 516170d4-4913-4577-a2d2-f5c52d1e79c6 | 2024-12-31 | Warnings, Adverse reactions | 075757 ANDA075757 0781-2868 0781-2859 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | ee0598a1-0e5e-40ff-ad88-b0adfc533ca0 | 2024-12-01 | Warnings, Adverse reactions | 075757 ANDA075757 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | 17664f71-154a-47c6-b83c-b349bbc8a98f | 2024-08-08 | Warnings, Adverse reactions | 075757 ANDA075757 71335-9609 |
| Omeprazole | OMEPRAZOLE | Sandoz Inc | e4562da8-9d94-4417-9f80-c1ffd4247259 | 2023-04-30 | Warnings, Adverse reactions | 075757 ANDA075757 0781-2790 0781-2785 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-1359 | Omeprazole | Omeprazole | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7933 | Omeprazole | Omeprazole | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7933 | Omeprazole | Omeprazole | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8320 | Omeprazole | Omeprazole | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8320 | Omeprazole | Omeprazole | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8320 | Omeprazole | Omeprazole | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0781-2785 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2785 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2785 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2785 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2790 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2790 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2790 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2790 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2859 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2859 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2859 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2859 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2868 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2868 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2868 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2868 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 50090-2901 | Omeprazole | Omeprazole | A-S Medication Solutions | ANDA | Current |
| 60760-868 | Omeprazole | Omeprazole | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-868 | Omeprazole | Omeprazole | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-868 | Omeprazole | Omeprazole | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-868 | Omeprazole | Omeprazole | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-868 | Omeprazole | Omeprazole | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 67046-700 | Omeprazole | Omeprazole | Contract Pharmacy Services-PA | ANDA | Current |
| 68071-2655 | Omeprazole | Omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 70518-0905 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0905 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1019 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1019 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2295 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2295 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2295 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2295 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2295 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70934-335 | Omeprazole | Omeprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-335 | Omeprazole | Omeprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-335 | Omeprazole | Omeprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-0559 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0559 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0559 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0559 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-9609 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |